Berberol P for Mild-to-Moderate Hypercholesterolaemia

Change in Total Cholesterol From Baseline

Change in serum total cholesterol concentration from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline

Change in serum HDL-C concentration from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Triglycerides From Baseline

Change in serum triglyceride concentration from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Fasting Blood Glucose From Baseline

Change in fasting blood glucose concentration (mg/dL) from baseline to the end of treatment.

Time frame: Baseline to Week 12

Change in Glycated Hemoglobin (HbA1c) From Baseline

Change in HbA1c (%) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Fasting Insulin From Baseline

Change in fasting serum insulin concentration from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Systolic Blood Pressure From Baseline

Change in systolic blood pressure (mmHg) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Diastolic Blood Pressure From Baseline

Change in diastolic blood pressure (mmHg) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Heart Rate From Baseline

Change in heart rate (beats per minute) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Incidence of Adverse Events

Number and proportion of participants experiencing adverse events during the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Safety Laboratory Parameters From Baseline

Change from baseline to Week 12 in safety laboratory parameters, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), C-reactive protein (CRP), and creatinine.

Time frame: Baseline to Week 12

Change in Body Weight From Baseline

Change in body weight (kg) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Waist Circumference From Baseline

Change in waist circumference (cm) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Non-HDL Cholesterol From Baseline

Change in calculated non-HDL cholesterol concentration from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol From Baseline

Change in calculated VLDL cholesterol concentration (mg/dL) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Total Cholesterol to HDL Cholesterol Ratio (TC/HDL) From Baseline

Change in calculated total cholesterol to HDL cholesterol ratio (TC/HDL) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in LDL Cholesterol to HDL Cholesterol Ratio (LDL/HDL) From Baseline

Change in calculated LDL cholesterol to HDL cholesterol ratio (LDL/HDL) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Triglyceride to HDL Cholesterol Ratio (TG/HDL) From Baseline

Change in calculated triglyceride to HDL cholesterol ratio (TG/HDL) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Remnant Cholesterol From Baseline

Change in calculated remnant cholesterol concentration from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Apolipoprotein A1 (Apo A1) From Baseline

Change in Apo A1 concentration from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Apolipoprotein B (ApoB) From Baseline

Change in ApoB concentration (mg/dL) from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Change in Apolipoprotein B to Apolipoprotein A1 Ratio (ApoB/Apo A1) From Baseline

Change in the calculated ApoB/Apo A1 ratio from baseline to the end of the 12-week treatment period.

Time frame: Baseline to Week 12

Severity of Undesirable Symptoms

Severity of undesirable symptoms during treatment, including myalgias, cramps, nausea, diarrhea, constipation, abdominal pain, asthenia, and headache, assessed by participants on a 0 to 10 scale, where 0 indicates "no problem" and 10 indicates "very severe problem," based on symptoms experienced during the previous 7 days.

Time frame: Baseline to Week 12

Frequency of Undesirable Symptoms

Frequency of undesirable symptoms, including myalgias, cramps, nausea, diarrhea, constipation, abdominal pain, asthenia, and headache. For each symptom present, participants will report its frequency as occasional, intermittent, or daily.

Time frame: Baseline to Week 12

Participant-Reported Treatment Tolerability Score on a 0-10 Scale

Treatment tolerability will be assessed by participants at Week 12 using the protocol-defined 0-10 numerical rating scale and recorded in the case report form (CRF).

Time frame: Week 12

Participant-Reported Treatment Adherence Percentage

Treatment adherence will be assessed at Week 12 using the protocol-defined 0-100% adherence scale recorded in the CRF.

Time frame: Week 12

Treatment Adherence Based on Returned Unused Tablets

Treatment adherence will be assessed at Week 12 based on the number of unused study tablets returned by participants at the end of the treatment period.

Time frame: Week 12